Mild and Moderate Atopic Dermatitis PatientsNCT07653386
Clinical Trial of an Ointment in Patients With Mild and Moderate Atopic Dermatitis
A study testing S.formosum-containing ointment and commercial moisturizer in people with Mild and Moderate Atopic Dermatitis Patients and Atopic Dermatitis (AD), run by VinUniversity at 1 site in Vietnam.
Trial summary
Atopic dermatitis (AD) is a chronic skin disorder, which negatively impacts up to 20% children and 3% adults in the world. The main AD treatments aim to regress clinical manifestations, improve and restore skin lesions. Read more about this study
- Who is it for?
- Ages 1 year to 30 years
- Conditions the study is for
- Mild and Moderate Atopic Dermatitis Patients, Atopic Dermatitis (AD)
- What is being tested?
- S.formosum-containing ointment and commercial moisturizer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteVietnam
- Study dates
- 23 Feb 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 1 and 30 years of age
- Definitive diagnosis of AD according to the Hanifin and Rajka criteria SCORAD scores: < 25: mild AD, 26- 50: moderate AD
- Total IgE and eosinophil measurements could be performed to access disease severity
Who cannot join
- Non-adherence to therapy
- Presence of other active skin diseases
- Severe AD within 1 month prior to enrollment
- Any concomitant disease that in the investigators' judgment, could interdere with treatment
- Current systemic treatment or use of immunosuppressive or immunomodulatory agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial to Evaluate the Safety and Efficacy of Theraphytoabel Theraphyto Intensive-Cure Ointment Product in Mild and Moderate Atopic Dermatitis Patients at Vinmec International Hospital Times City
Atopic dermatitis (AD) is a chronic skin disorder, which negatively impacts up to 20% children and 3% adults in the world. The main AD treatments aim to regress clinical manifestations, improve and restore skin lesions. Daily moisturizing has also been shown to have the ability to protect the skin, increase skin elasticity and reduce the severity of AD. In the past few decades, Korea has been a well-known country with cosmetic companies and products derived from nature. Carboexpert is also one of them. Since its inception, the company has focused on researching and developing herbal extracts in skin care cosmetic products, typically the product Theraphytoabel Theraphyto Intensive-Cure Ointment. The product uses a high concentration of extract from Syzygium formosum (Wall) masam leaves originating from Vietnam. This is a medicinal herb that has been used in Vietnam for hundreds of years. Folk remedies in Vietnam use hot water leaf extract of this plant to treat urticaria and rashes. Previous studies have shown that leaf extract has also been shown to be very effective against gram-positive bacteria. The study in 2018 also demonstrated that the ethanol extract of S. formosum leaves was effective in reducing food allergy on mouse model. Based on the above evidences, this study will evaluate and compare the effectiveness and safety between Theraphytoabel Theraphyto Intensive-Cure Ointment product and commercial moisturizers which using in Vinmec on moderate and mild AD patients at Vinmec International Hospital Times City, Hanoi.
- Being tested
- S.formosum-containing ointment, commercial moisturizer
- Keywords
- Steroid-sparing, Th2 cytokines, S. formosum-containing ointment, atopic dermatitis, clinical trial, Transepidermal water loss (TEWL), stratum corneum hydration (SCH), Scoring atopic dermatitis (SCORAD)
- Medical subject headings
- Lymphoma, Follicular, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S.formosum-containing ointmentOther
Also called Theraphytoabel Theraphyto Intensive-Cure Ointment
The test ointment used in this study is Theraphytoabel Theraphyto Intensive-Cure Ointment (Carboexpert Inc., Daejeon, Korea), which contains various components, including herbal extracts. The content of S. Formosum leaf Extract is 0.35%
commercial moisturizerOther
One of the moisturizers approved for use in patients with atopic dermatitis at Vinmec Times City
| Study group | Role | What they receive |
|---|---|---|
| Commercial group | Active comparator | Commercial moisturizer group will be applied standard therapy by topical commercial moisturizers using in Vinmec combined with or without topical corticosteroids within 3 months. During this period, any patients have exacerbation, they will be treated rescue therapy as prescription with or without topical corticosteroids. Receives: Other: commercial moisturizer |
| Theraphyto group | Experimental | S. formosum-containing ointment group will be applied standard therapy by topical Theraphytoabel Theraphyto Intensive-Cure Ointment combined with or without topical corticosteroids within 3 months. During this period, any patients have exacerbation, they will be treated rescue therapy as prescription with topical corticosteroids. Receives: Other: S.formosum-containing ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical assessment of AD severity
AD global severity will be assessed using the SCORAD index, a validated clinical tool. The intensity of redness, swelling, oozing/ crusting, scratch marks, lichenification and dryness will be measured over the whole body. Subjective symptoms of itch and sleeplessness were measured and skin lesion photographs were taken at every visit.
Measured: week 0, 4, 8, 12
Secondary outcomes (3)
Assessment of changes in transepidermal water loss
Transepidermal water loss (TEWL) will be measured to assess changes in skin barrier function at baseline and after treatment using a moisturizer. Measurements will be performed on predefined lesional skin areas using GPSKIN barrier research solution 1 device (GPOWER Inc., Gyeonggi-do, South Korea) throughout the 12-week treatment, under standardized environmental conditions (room temperature 19-25°C and relative humidity 50-58%). Participants will be instructed to avoid applying topical products to the assessment site for at least 12 hours and to acclimatize in the examination room for 15 minutes before measurement. Three consecutive TEWL readings will be obtained at each assessment, and the mean value, expressed in g/m²/h, will be used for analysis.
Measured: All patients will be measured at week 0 (baseline), 4, 8, 12.
Accessment the changes of Stratum corneum hydration (SCH)
Stratum corneum hydration (SCH) will be assessed to evaluate changes in skin moisture content at baseline and after treatment using a moisturizer. Measurements will be performed on the same predefined lesional skin areas using GPSKIN barrier research solution 1 device (GPOWER Inc., Gyeonggi-do, South Korea) throughout the 12-week treatment, under standardized environmental conditions (room temperature 19-25°C and relative humidity 50-58%). Participants will be instructed to avoid applying topical products to the assessment site for at least 12 hours and to acclimatize in the examination room for 15-20 minutes before measurement. Three consecutive SCH readings will be obtained at each assessment, and the mean value, expressed in arbitrary units (a.u.) will be used for analysis.
Measured: week 0 (baseline), 4, 8, 12
Evaluate changes in cytokine levels
Cytokine levels of interleukin (IL)-4, IL-13, IL-5 and thymic stromal lymphopoietin (TSLP) in serum will be analyzed using ELISA cytokine kits, Duoset (Bio-Techne, Minneapolis, MN, USA) according to the manufacturer's recommendations.
Measured: week 0, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start23 Feb 2025
- Primary completion31 Oct 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild and Moderate Atopic Dermatitis PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- VinUniversity
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nguyen Thi Minh Nguyet, VinUniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653386
- Sponsor's protocol ID
- 24.10.VVI
- Other IDs
- 24.10.VVI
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate the Safety and Efficacy of Theraphytoabel Theraphyto Intensive-Cure Ointment Product in Mild and Moderate Atopic Dermatitis Patients at Vinmec International Hospital Times City
- ClinicalTrials.gov ID
- NCT07653386
- Acronym / sponsor ID
- 24.10.VVI
- Keywords
- Steroid-sparing, Th2 cytokines, S. formosum-containing ointment, atopic dermatitis, clinical trial, Transepidermal water loss (TEWL), stratum corneum hydration (SCH), Scoring atopic dermatitis (SCORAD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- VinUniversityUniversity, hospital or other
- Study start
- 23 Feb 2025 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atopic dermatitis (AD) is a chronic skin disorder, which negatively impacts up to 20% children and 3% adults in the world. The main AD treatments aim to regress clinical manifestations, improve and restore skin lesions. Daily moisturizing has also been shown to have the ability to protect the skin, increase skin elasticity and reduce the severity of AD. In the past few decades, Korea has been a well-known country with cosmetic companies and products derived from nature. Carboexpert is also one of them. Since its inception, the company has focused on researching and developing herbal extracts in skin care cosmetic products, typically the product Theraphytoabel Theraphyto Intensive-Cure Ointment. The product uses a high concentration of extract from Syzygium formosum (Wall) masam leaves originating from Vietnam. This is a medicinal herb that has been used in Vietnam for hundreds of years. Folk remedies in Vietnam use hot water leaf extract of this plant to treat urticaria and rashes. Previous studies have shown that leaf extract has also been shown to be very effective against gram-positive bacteria. The study in 2018 also demonstrated that the ethanol extract of S. formosum leaves was effective in reducing food allergy on mouse model. Based on the above evidences, this study will evaluate and compare the effectiveness and safety between Theraphytoabel Theraphyto Intensive-Cure Ointment product and commercial moisturizers which using in Vinmec on moderate and mild AD patients at Vinmec International Hospital Times City, Hanoi.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Commercial group | Active comparator | Other: commercial moisturizerCommercial moisturizer group will be applied standard therapy by topical commercial moisturizers using in Vinmec combined with or without topical corticosteroids within 3 months. During this period, any patients have exacerbation, they will be treated rescue therapy as prescription with or without topical corticosteroids. |
| Theraphyto group | Experimental | Other: S.formosum-containing ointmentS. formosum-containing ointment group will be applied standard therapy by topical Theraphytoabel Theraphyto Intensive-Cure Ointment combined with or without topical corticosteroids within 3 months. During this period, any patients have exacerbation, they will be treated rescue therapy as prescription with topical corticosteroids. |
Who may qualify
- Ages
- 1 year to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age between 1 and 30 years of age
- Definitive diagnosis of AD according to the Hanifin and Rajka criteria SCORAD scores: < 25: mild AD, 26- 50: moderate AD
- Total IgE and eosinophil measurements could be performed to access disease severity
Key exclusion criteria (5 listed)
- Non-adherence to therapy
- Presence of other active skin diseases
- Severe AD within 1 month prior to enrollment
- Any concomitant disease that in the investigators' judgment, could interdere with treatment
- Current systemic treatment or use of immunosuppressive or immunomodulatory agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S.formosum-containing ointmentAlso: Theraphytoabel Theraphyto Intensive-Cure OintmentThe test ointment used in this study is Theraphytoabel Theraphyto Intensive-Cure Ointment (Carboexpert Inc., Daejeon, Korea), which contains various components, including herbal extracts. The content of S. Formosum leaf Extract is 0.35% | Other | Theraphyto group |
| commercial moisturizerOne of the moisturizers approved for use in patients with atopic dermatitis at Vinmec Times City | Other | Commercial group |
Primary outcome
Clinical assessment of AD severity
Time frame: week 0, 4, 8, 12
AD global severity will be assessed using the SCORAD index, a validated clinical tool. The intensity of redness, swelling, oozing/ crusting, scratch marks, lichenification and dryness will be measured over the whole body. Subjective symptoms of itch and sleeplessness were measured and skin lesion photographs were taken at every visit.
3 secondary outcomes
Assessment of changes in transepidermal water loss
Time frame: All patients will be measured at week 0 (baseline), 4, 8, 12.
Accessment the changes of Stratum corneum hydration (SCH)
Time frame: week 0 (baseline), 4, 8, 12
Evaluate changes in cytokine levels
Time frame: week 0, 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing S.formosum-containing ointment and commercial moisturizer in people with Mild and Moderate Atopic Dermatitis Patients and Atopic Dermatitis (AD), run by VinUniversity at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical assessment of AD severity (time frame: week 0, 4, 8, 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.